NCT01399671

Brief Summary

Major depression is characterized by vestibular anomalies. The investigators hypothesized that vestibular stimulation will improve depression symptoms in major depression patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

July 12, 2011

Last Update Submit

March 2, 2012

Conditions

DepressionMajor DepressionVestibular Disorders

Keywords

depressionvestibular

Outcome Measures

Primary Outcomes (1)

  • Hamilton depression rating score

    1 month after the treatment start

Interventions

vestibular stimulationOTHER

vestibular stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major depression patients,
  • actual Hamilton score \> 14

You may not qualify if:

  • pregnant,
  • neurological disorders,
  • epilepsy,
  • bipolar disorder,
  • schizophrenia,
  • anorexia,
  • bulimia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Medicina Aeroespacial

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Ana M Soza, MD

    Fuerza Aerea de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 22, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 5, 2012

Record last verified: 2011-03

Locations

CL(1)